Device Survival Probability

D3xxDRx_SURV

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1 yr

2 yr

3 yr

4 yr

5 yr

at 66.0 mo

%

100.0

100.0

99.9

99.9

99.9

99.9

%

99.9

99.8

99.5

99.1

97.2

92.1

#

55724

52226

47430

31965

8496

541

Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.

EOS Indication

The Prolonged Service Period (PSP) is the time between the RRT and EOS. The PSP is defined as 3 months assuming the following conditions: 100% DDD pacing at 60 min-1, 2.5 V atrial and RV pacing amplitude; 0.4 ms pulse width; 600 Ω pacing load; and 6 full-energy charges. The EOS may be indicated before the end of 3 months if the device exceeds these conditions.

Distribution Data

US Market Release

2011-03-25

CE Approval Date

Registered USA Implants

34814

Estimated Active USA Implants

26820

Normal Battery Depletions

314

US Market Release

2011-03-25

CE Approval Date

Estimated WW Distribution

35468

Normal Battery Depletions

314

Malfunctions (USA)

Therapy Function Not Compromised

30

Battery

3

Electrical Component

23

Possible Early Battery Depletion

3

Other

1

Therapy Function Compromised

6

Electrical Component

6

Malfunctions (WW)

Therapy Function Not Compromised

31

Battery

3

Electrical Component

23

Possible Early Battery Depletion

3

Other

2

Therapy Function Compromised

6

Electrical Component

6

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.63V on 3 consecutive daily automatic measurements.